Positive COMFORT-1 Phase III Results for Can-Fite's Psoriasis Treatment Published

3 June 2024
Piclidenoson, a novel oral medication, has shown promise for the long-term management of individuals with moderate to severe plaque psoriasis. The drug's effectiveness and safety were recently highlighted in an article published in the Journal of the European Academy of Dermatology and Venereology (EADV), a prestigious peer-reviewed journal with an impact factor of 9.2.

Dr. K.A Papp, a leading authority in psoriasis treatment and instrumental in the development of several market-available drugs for the condition, is the primary author of the study. The research details the outcomes of a randomized, double-blind, Phase III COMFORT-1 trial, which compared Piclidenoson to a placebo and an active control group. The trial demonstrated that Piclidenoson met its primary endpoint, with a significant number of patients experiencing at least a 75% improvement in Psoriasis Area and Severity Index (PASI) scores by Week 16. The drug's efficacy was observed to increase linearly over the study's duration, coupled with a favorable safety and tolerability profile.

Piclidenoson is currently under evaluation in the COMFORT-2 trial, a pivotal Phase III study that has received approval from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Dr. Fishman, the Chief Scientific Officer and Executive Chairman of Can-Fite BioPharma Ltd., expressed optimism about the drug's potential impact on psoriasis treatment. He anticipates initiating patient treatment in the pivotal trial soon and hopes that Piclidenoson will emerge as a preferred oral treatment option for psoriasis patients, given its demonstrated safety and efficacy.

Piclidenoson is a groundbreaking A3 adenosine receptor agonist (A3AR) small molecule with an excellent safety profile. It has shown efficacy in Phase II and III trials for psoriasis. The drug works by inhibiting inflammatory cytokines IL-17 and IL-23 and inducing apoptosis in skin cells involved in the disease's pathology. Beyond psoriasis, Piclidenoson is also being co-developed for the treatment of Lowe Syndrome, a rare genetic disorder.

Can-Fite BioPharma Ltd., the company behind Piclidenoson, is an advanced clinical-stage drug development firm focused on addressing significant markets in cancer, liver, and inflammatory disease treatments. In addition to Piclidenoson, the company is developing Namodenoson, which is in various stages of clinical trials for different indications, including steatotic liver disease, hepatocellular carcinoma, and pancreatic cancer. Namodenoson has received Orphan Drug Designation and Fast Track Designation from the FDA. The company's third drug candidate, CF602, has shown potential in treating erectile dysfunction. With a strong safety record in over 1,600 patients, Can-Fite continues to innovate in the pharmaceutical industry.

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